Enlude Tablet 1.0 mg (Entecavir Hydrate)

Adult dose

Take this medicine orally on an empty stomach (2 hours after a meal or at least 2 hours before a meal). The recommended dose is 0.5mg of entecavir once daily by mouth. Patients with lamivudine resistance, i.e., patients 16 years of age or older who experienced persistent replication of hepatitis B virus despite lamivudine treatment or who have lamivudine-resistant mutations: 1mg of entecavir once daily on an empty stomach Patients with renal impairment: As creatinine clearance decreases in patients with renal impairment, the oral clearance of this medicine decreases. Adjust the dose as follows in patients with creatinine clearance below 50mL/min, including those receiving hemodialysis or continuous ambulatory peritoneal dialysis (CAPD). Creatinine clearance (mL/min) ≥ 50: entecavir dose 0.5 mg once daily; entecavir dose for patients with lamivudine resistance 1 mg once daily Creatinine clearance (mL/min) 30 - <50: entecavir dose 0.25 mga once daily or 0.5 mg every 48 hours; entecavir dose for patients with lamivudine resistance 0.5 mg once daily or 1 mg every 48 hours Creatinine clearance (mL/min) 10 - <30: entecavir dose 0.15 mga once daily or 0.5 mg every 72 hours; entecavir dose for patients with lamivudine resistance 0.3 mga once daily or 1 mg every 72 hours Creatinine clearance (mL/min) <10, hemodialysisb or CAPD: entecavir dose 0.05 mga once daily or 0.5 mg every 7 days; entecavir dose for patients with lamivudine resistance 0.1 mga once daily or 1 mg every 7 days a : For doses below 0.5mg, use of the syrup formulation is recommended. b : If administered on a hemodialysis day, administer this medicine after the hemodialysis session.

This medication may cause serious side effects that can affect the liver; therefore, special caution is required for patients with poor liver function or at risk for liver disease. If symptoms such as lactic acidosis or liver function abnormalities occur during treatment, the use of the medication should be discontinued immediately, and tests should be conducted as directed by a physician. Discontinuation of this medication can lead to a sudden worsening of hepatitis B, thus liver function must be closely monitored for several months after discontinuation. Patients co-infected with HIV and hepatitis B should not use this medication alone, as it may interfere with HIV treatment; they must be receiving HIV treatment. Patients with hypersensitivity to this medication or any genetic issues like lactose intolerance should not use it. Dose adjustments are necessary for patients with decreased kidney function or undergoing dialysis, and liver transplant patients must closely monitor renal function and drug interactions. Taking this medication with food can reduce drug absorption, so it is advisable to take it on an empty stomach. During pregnancy, it should only be used when absolutely necessary due to risks to the fetus, and during breastfeeding, either breastfeeding should be stopped or the medication should be discontinued. Use is recommended only for children aged 2 years and older; safety and efficacy have not been established in children under the age of 2. While taking this medication, side effects such as headache, fatigue, dizziness, dyspepsia, and nausea may occur; if unusual symptoms arise, consult a physician. In case of overdose, there is no specific antidote, so appropriate treatment should be provided based on symptoms, and blood dialysis may be performed to remove some of the medication if necessary. This medication is primarily excreted through the kidneys, so when used with other medications that affect kidney function, careful monitoring for side effects should be conducted. Store it out of reach of children, avoid direct sunlight, and keep it at room temperature.

Lactic acidosis, lipidosis, hepatomegaly, impaired liver metabolic function, headache, fatigue, dizziness, nausea, diarrhea, indigestion, vomiting, lightheadedness, drowsiness, insomnia, anaphylactic reactions, increased aminotransferases, hair loss, rash, upper abdominal pain, heartburn, chest pain, indigestion, hematuria, thrombocytopenia, hyperglycemia, diabetes, cold, itching, constipation, abdominal pain, back pain, abdominal discomfort, runny nose, liver neoplasm, intra-abdominal hemorrhage, ascites, portal hypertension-related gastrointestinal disease, gastrointestinal bleeding, cholangitis, hepatic encephalopathy, deviated septum, sepsis, eyelid skin disorders, gastric angioectasia, chronic sinusitis, abdominal pain, rash, bad taste, neutropenia

This medication must be stored in a tightly closed container to avoid exposure to air and light, and it should be kept away from direct sunlight. It is important to maintain a storage temperature between 15 and 30 degrees Celsius.

Appearance

Pink, triangular film-coated tablets

Package unit

30 tablets/PTP